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FDA 510(k)

WIRE GUIDED OVAL DILATORS

K-Number: K930465 · 1993-05-21

ApplicantSurgical Technologies, Inc.
Decision Date1993-05-21
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

WIRE GUIDED OVAL DILATORS is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Technologies, Inc.. It received FDA 510(k) clearance on 1993-05-21 under 510(k) number K930465. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WIRE GUIDED OVAL DILATORS?

WIRE GUIDED OVAL DILATORS is a medical device that received FDA 510(k) clearance on 1993-05-21. The listed applicant is Surgical Technologies, Inc.. The 510(k) number is K930465.

When did WIRE GUIDED OVAL DILATORS receive FDA 510(k) clearance?

WIRE GUIDED OVAL DILATORS received FDA 510(k) clearance on 1993-05-21, under 510(k) number K930465.

Who is the listed applicant for WIRE GUIDED OVAL DILATORS?

The FDA 510(k) record lists Surgical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WIRE GUIDED OVAL DILATORS?

The FDA product code for WIRE GUIDED OVAL DILATORS is GCJ.

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Other records listing Surgical Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K941992CYSTOSCOPEK942029ARTHROSCOPEK946136INFINITECH LIGHTED INFUSION CANNULAK952566OSCILFLATORK951918SURGICAL TECHNOLOGIES, INC. SYRINGEK950683ARTHROGRAM TRAY

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Related Devices (Code: GCJ)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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